Was great to be at the meeting today. Met several others including youseff, matagorville and cabel. Meeting was well attended. Midway through the presentation I did a head count of what I believed to be shareholders (excluding an obvious employees) and counted to the high 40s, probably 48.
All of this my own opinion, piece it together with others who attended. As a salute to Drano, for a limited time this piece will be exclusive to this board, I will probably paste it tomorrow to IHUB.
Just wanted to list some information, this is not a comprehensive list:
*.6 mg dose will be used in phase 3 for Brilacidin (I think we already knew that)
*P data will be available end of April, early May 115 total patients enrolled, 10% have completed the 84 days of the trial
*To date P trial has had no events that would make them worry about the trial (as good as can be, but they don't know efficacy until they get the results after the blinded trial).
*Rosen may get 60 more days but CTIX is trying to get them to decide on Friday to not grant them another extension
*Rosen process has to play out
*Leo stated high level SEC lawyers are involved and state and federal prosecutors involved. Leo also mentioned the FBI
*B 2 global trials should . The first will have interim analysis after 200 patients. Both trials will run concurrent, but not start at the same time. Dr. J expects 18 month to complete a phase 3 trial. 6 months to interim results from start.
*B-OM ( I hope I don't embellish to much here but) 10 sites planned and more being considered. an independent review will happen after 36 patients have completed treatment. Trial could end after independent review or they could decide to continue through all 60 patients. Interim analysis could be in a few months. No count of enrolled.
*UP - already finishing protocol for this trial. Seems to be moving quickly. Makes me think they are preparing for the possibility that B-OM will conclude after independent review, though this is just my speculation.
*K not cytotoxic due to low toxicity. Leo says he needs to wait unitl the next meeting with the FDA before giving more information on that trial. Leo said they are seriously considering including a pump and IV approach going forward. Since it is not toxic and they believe longer exposure will increase efficacy, IV and pump at home could give longer exposure to patients. Planning on IV 2X week for Ovarian trial. I asked a question about the MTD vs MAD and Menon said something to the effect that MTD is more commonly used with cytotoxic drugs and since K is not cytotoxic they do not need to pursue that further. Leo also mentioned that he could dose patients at 750 or more, but that was not what was needed. Longer exposure is what will increase benefit.
*Leo does not believe he will partner B for ABSSSI before phase 3 is complete.
*For nasdaq Leo stated they met all criteria except share price requirement. And it is $2 for 90 days.
*UofB is shelved for the time being. Leo will pursue this in US with grants when they have ovarian trial results.
*Leo believes the start of B phase 3 will have a positive impact on share price, the results of P could have a positive impact, the B-OM results, K results etc.
*He also mentioned he wants to add a big name to the BOD. Started the process and should happen in Q1.
Have to leave for a while. I will probably answer questions tomorrow. I hurried this to get it out, did not edit/proofread...
All of this my own opinion, piece it together with others who attended. As a salute to Drano, for a limited time this piece will be exclusive to this board, I will probably paste it tomorrow to IHUB.
Just wanted to list some information, this is not a comprehensive list:
*.6 mg dose will be used in phase 3 for Brilacidin (I think we already knew that)
*P data will be available end of April, early May 115 total patients enrolled, 10% have completed the 84 days of the trial
*To date P trial has had no events that would make them worry about the trial (as good as can be, but they don't know efficacy until they get the results after the blinded trial).
*Rosen may get 60 more days but CTIX is trying to get them to decide on Friday to not grant them another extension
*Rosen process has to play out
*Leo stated high level SEC lawyers are involved and state and federal prosecutors involved. Leo also mentioned the FBI
*B 2 global trials should . The first will have interim analysis after 200 patients. Both trials will run concurrent, but not start at the same time. Dr. J expects 18 month to complete a phase 3 trial. 6 months to interim results from start.
*B-OM ( I hope I don't embellish to much here but) 10 sites planned and more being considered. an independent review will happen after 36 patients have completed treatment. Trial could end after independent review or they could decide to continue through all 60 patients. Interim analysis could be in a few months. No count of enrolled.
*UP - already finishing protocol for this trial. Seems to be moving quickly. Makes me think they are preparing for the possibility that B-OM will conclude after independent review, though this is just my speculation.
*K not cytotoxic due to low toxicity. Leo says he needs to wait unitl the next meeting with the FDA before giving more information on that trial. Leo said they are seriously considering including a pump and IV approach going forward. Since it is not toxic and they believe longer exposure will increase efficacy, IV and pump at home could give longer exposure to patients. Planning on IV 2X week for Ovarian trial. I asked a question about the MTD vs MAD and Menon said something to the effect that MTD is more commonly used with cytotoxic drugs and since K is not cytotoxic they do not need to pursue that further. Leo also mentioned that he could dose patients at 750 or more, but that was not what was needed. Longer exposure is what will increase benefit.
*Leo does not believe he will partner B for ABSSSI before phase 3 is complete.
*For nasdaq Leo stated they met all criteria except share price requirement. And it is $2 for 90 days.
*UofB is shelved for the time being. Leo will pursue this in US with grants when they have ovarian trial results.
*Leo believes the start of B phase 3 will have a positive impact on share price, the results of P could have a positive impact, the B-OM results, K results etc.
*He also mentioned he wants to add a big name to the BOD. Started the process and should happen in Q1.
Have to leave for a while. I will probably answer questions tomorrow. I hurried this to get it out, did not edit/proofread...
